Product code NSA— Cardiovascular
PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
- Classification name
- Over-The-Counter Automated External Defibrillator
- Device class
- Class 3
- Regulation
- 21 CFR 870.5310
- Advisory panel
- Cardiovascular
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs.”
Market context for product code NSA
FDA has cleared device under product code NSA, all in 2004, filed by 1 applicant company. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.
Top applicants under product code NSA
Adverse events under product code NSA
product code NSA- Death
- 21
- Malfunction
- 961
- Total
- 982
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NSA
Data sourced from openFDA. This site is unofficial and independent of the FDA.